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510(k) K101791

ROSA SURGICAL DEVICE by Medtech S.A.S — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2010
Date Received
June 28, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurological Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
NE
Submission Type

Other clearances by Medtech S.A.S

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  • K214065 — ROSA ONE Brain application (May 4, 2022)
  • K200511 — ROSA ONE Brain application (May 29, 2020)
  • K192173 — ROSA ONE Spine application (October 29, 2019)
  • K182848 — ROSA ONE Spine application (March 22, 2019)
  • K182417 — ROSA ONE Brain Application (February 7, 2019)
  • K172444 — ROSA BRAIN (v3.0.0.5) (March 28, 2018)
  • K151511 — ROSA Spine (January 4, 2016)
  • K151359 — ROSA Brain (December 18, 2015)
  • K092239 — ROSA SURGICAL DEVICE, MODEL ROSA 1.1 (November 17, 2009)

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